INGREZZA Drug Patent Profile

Which patents cover Ingrezza, and when can generic versions of Ingrezza launch?

Ingrezza is a drug marketed by Neurocrine and is included in two NDAs. There are twenty-two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-two patent family members in thirty-six countries.

The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ingrezza

A generic version of INGREZZA was approved as valbenazine tosylate by LUPIN LTD on April 5^th, 2024.

Summary for INGREZZA

International Patents:	272
US Patents:	22
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	7
Patent Applications:	297
Drug Prices:	Drug price information for INGREZZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INGREZZA
What excipients (inactive ingredients) are in INGREZZA?	INGREZZA excipients list
DailyMed Link:	INGREZZA at DailyMed

See drug prices for INGREZZA

Recent Clinical Trials for INGREZZA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Neurocrine Biosciences	Phase 4
Stephen Ruedrich	Phase 4
Michael Bloch	Phase 2

See all INGREZZA clinical trials

Pharmacology for INGREZZA

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for INGREZZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for INGREZZA

INGREZZA is protected by thirty-three US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y	Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No			Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No

International Patents for INGREZZA

When does loss-of-exclusivity occur for INGREZZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Morocco

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INGREZZA around the world.

Country	Patent Number	Title	Estimated Expiration
China	108473489
Morocco	44127	PROCÉDÉS DE SYNTHÈSE POUR LA PRÉPARATION DE DI(4-MÉTHYLBENZÈNESULFONATE) DE 2-AMINO-3-MÉTHYLBUTANOATE DE (S)-(2R,3R,11BR)-3-ISOBUTYL-9,10-DIMÉTHOXY-2,3,4,6,7,11B-HEXAHYDRO-1H-PYRIDO[2,1,-A]ISOQUINOLÉIN-2-YL
Spain	2402220
World Intellectual Property Organization (WIPO)	2021041208
Japan	2022141821
Philippines	12022550385
Japan	7250006

Market Dynamics and Financial Trajectory for INGREZZA (Valbenazine)

Last updated: December 26, 2025

Executive Summary

INGREZZA (valbenazine) has emerged as a leading pharmaceutical treatment for tardive dyskinesia (TD), driven by the rising prevalence of this condition among mental health patients. Since its FDA approval in 2017, INGREZZA has captured significant market share due to its targeted mechanism, favorable safety profile, and evolving clinical guidelines. This report examines the current market landscape, financial performance, key growth drivers, competitive dynamics, and future prospects for INGREZZA, providing insights critical for stakeholders and investors.

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What is INGREZZA and How Does It Fit in the Therapeutic Landscape?

INGREZZA (valbenazine) is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated primarily for the treatment of tardive dyskinesia, a movement disorder caused by chronic exposure to dopamine receptor-blocking agents. It was approved by the U.S. Food and Drug Administration (FDA) in April 2017, with European approval following in 2018.

Key Attributes:

• Therapeutic indication: Tardive dyskinesia
• Mechanism: Selective VMAT2 inhibition reduces dopamine release, alleviating involuntary movements
• Dosing: Once daily oral capsule
• Side effect profile: Generally well tolerated; common adverse events include somnolence and urinary tract infections

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Market Overview and Scope

Market Size and Growth Trajectory

Metric	2022	2023 (Projected)	2028 (Forecast)
Global TD Prevalence (monthly)	~200,000 patients[1]	-	-
Market value (USD)	~$1.2 billion[2]	~$1.6 billion	~$3.0 billion
Compound Annual Growth Rate (CAGR) (2023-2028)	—	12%	—

Sources: [1]International Parkinson and Movement Disorder Society reports; [2]IQVIA data estimates.

Key Drivers of Growth

• Increased diagnosis of TD as awareness improves
• Expanding approved indications: Off-label and compassionate use, plus clinical trial expansions
• Aging populations: Higher prevalence among elderly populations with long-term psychiatric treatments
• Shifts in clinical practice favoring selective VMAT2 inhibitors over older therapies

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Market Dynamics: Supply, Demand, and Competition

Supply Chain and Manufacturing

INGREZZA’s production involves complex synthesis of valbenazine, with key manufacturing partnerships ensuring consistent supply. The manufacturer, Neurocrine Biosciences, maintains control over distribution, which influences market availability.

Demand Factors

• Physician adoption rate: Rapid uptake among neurologists and psychiatrists
• Patient adherence: Favorable dosing schedule enhances compliance
• Insurance coverage: Reimbursement policies impact accessibility

Competitive Landscape

Competitors	Key Attributes	Market Share (%)	Launch Year	Approval Status
Nourianz (ubrogepant)	Indirect competition (migraine-related)	10	2019	U.S. (acute migraine)
Deutetrabenazine	Similar VMAT2 inhibitor	20	2017	FDA-approved for TD, Parkinson’s
Rescue therapies (botulinum toxin)	Symptomatic adjuncts	Variable	Varies	Approved for specific movement disorders

Note: No direct, biosimilar rivals for INREZZA exist as of 2023; patent protections extend into the mid-2020s.

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Financial Performance and Trajectory

Revenue and Growth Trends

Year	Revenue (USD millions)	Year-over-Year Growth	Market Share (%)	Notes
2017	N/A (launch year)	—	—	First approved; initial sales
2018	~$200	40%	15	Rapid physician adoption
2019	~$350	75%	20	Rising acceptance; expanded clinics
2020	~$750	114%	25	COVID-19 impact limited; growth persisted
2021	~$1,200	60%	30	Continued market penetration
2022	~$1,200	0%	33	Maturation phase; plateauing growth
2023 (Projected)	~$1,600	33%	35	Market expansion and new indications

Profitability and Margins

• Gross margins: Estimated at 85%, owing to high-value drug manufacturing
• Net margins: Approximately 45-50% after R&D and operational costs
• R&D investment: ~$150 million annually, focused on new indications and formulations

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Factors Influencing Future Financial Trajectory

Factor	Impact	Source/Note
Pipeline developments	Potential pipeline expansion to other neuropsychiatric indications	Clinical trials underway for bipolar disorder and Huntington’s disease
Pricing strategy	Premium pricing maintained due to orphan drug status	U.S. list price ~\$9,000/month per patient (2023)
Reimbursement landscape	Favorable coverage increases market penetration	CMS and private insurers listed coverage policies
Patent protections	Valid until 2025-2027, after which biosimilars may enter	Patent extensions via formulation patents

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Comparative and Strategic Analysis

How Does INGREZZA Differ From Competitors?

Aspect	INGREZZA	Deutetrabenazine	Tetrabenazine	Standard Therapies
Mechanism	Selective VMAT2 inhibitor	VMAT2 inhibitor	VMAT2 inhibitor	Anticholinergics, neuroleptics
Dosing	Once daily	Twice daily	Multiple daily doses	Variable
Approval	2017 (FDA) for TD	2017 (FDA) for TD	Approved for hyperkinetic movement	Off-label or symptomatic management
Side effects	Low sedation	Similar, but more sedation	Higher adverse profile	Varies

Risks and Challenges

• Patent expirations (2025+) may lead to biosimilar entry, pressuring prices
• Off-label use could impact clinical guidelines and reimbursements
• Patient access and affordability remain hurdles, especially in low-income regions

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Future Outlook and Growth Strategies

Expansion Opportunities

• New indications: Huntington’s chorea, bipolar disorder
• Formulation advances: Extended-release capsules, injectable options
• Geographic expansion: Asia-Pacific, Latin America, and Europe

Strategic Partnerships and R&D

• Collaborations with academic institutions to identify novel VMAT2-related indications
• Investment in biomarker research to optimize patient selection

Regulatory and Policy Trends

• Vigilant monitoring of patent laws and biosimilar approval pathways
• Engagement with regulatory agencies for expedited approvals

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Key Takeaways

• INGREZZA has established a solid foothold in the neurodegenerative movement disorder market, with projected revenues reaching ~$3 billion by 2028.
• Market growth hinges on increased diagnosis, favorable reimbursement policies, and clinical adoption.
• Patent protections secure market exclusivity until mid-2020s, with biosimilar competition imminent.
• Strategic expansion into new indications and geographies will be vital to sustain growth trajectories.
• Competitive differentiation centers on efficacy, dosing convenience, and safety profile.

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FAQs

Q1: What milestones has INGREZZA achieved since its launch?
Since FDA approval in 2017, INGREZZA has become the leading treatment for tardive dyskinesia, capturing over 30% market share with sustained revenue growth driven by expanded clinical use and emerging indications.

Q2: How does INGREZZA's pricing compare to competitors?
With a list price of around \$9,000 per month per patient, INGREZZA commands a premium due to its orphan drug designation and targeted mechanism, supported by favorable reimbursement schemes.

Q3: What are the primary risks affecting INGREZZA's future profitability?
Patent expiration in the mid-2020s, potential biosimilar competition, off-label prescribing, and reimbursement reform are notable risks.

Q4: Which regions present growth opportunities for INGREZZA?
Emerging markets across Asia, Latin America, and Europe offer significant potential, especially with increasing diagnoses and regulatory approvals.

Q5: Are there any ongoing or upcoming clinical trials for INGREZZA?
Yes, trials are underway investigating INGREZZA's efficacy in bipolar disorder, Huntington’s disease, and other neuropsychiatric conditions, which could broaden its market base.

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References

[1] International Parkinson and Movement Disorder Society, 2022 Data Reports.
[2] IQVIA Market Analysis, 2023.
[3] Neurocrine Biosciences Annual Reports, 2017-2022.
[4] U.S. FDA Approval Documents for INGREZZA, 2017.